FDA Inspection
Unetixs Vascular, Inc.Unetixs Vascular, Inc. – FDA Inspection, Jul 30, 2021
Record Details
This FDA Inspection record concerns Unetixs Vascular, Inc., with an inspection on July 30, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Unetixs Vascular, Inc.
- Inspection Date
- July 30, 2021
- Product Type
- Devices
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ID · 2f918bc7-00ce-49e6-8a73-f5c8f6d223f7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1147542
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Unetixs Vascular, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| September 16, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 29, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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